Safety and Efficacy of Telbivudine on Liver Cirrhosis in Patients With Chronic Hepatitis B (CHB)

The Fifth People's Hospital of Suzhou

Status and phase

Unknown

Phase 4

Conditions

Liver Cirrhosis

Chronic Hepatitis B

Treatments

Drug: telbivudine

Study type

Interventional

Funder types

Other

Identifiers

NCT01380951

szwy20110610

Details and patient eligibility

About

Antiviral treatment on Chronic Hepatitis B (CHB) patients with liver cirrhosis is compulsory and effective. Telbivudine, which is superior to lamivudine in the treatment of CHB,is considered to be appropriate for the antiviral treatment on CHB patients with liver cirrhosis.

Full description

Antiviral therapy on CHB patients with liver cirrhosis is compulsory and effective. Diseases development can be prevented or delayed if the virus is depressed successfully. Lamivudine is often used and usually has good efficacy. However, lamivudine resistance and virus mutation happens a lot. Telbivudine, which is superior to lamivudine in the treatment of CHB,is considered to be appropriate for the antiviral treatment on CHB patients with liver cirrhosis.

Enrollment

120 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

liver cirrhosis with CHB
without history of antiviral therapy or discontinued antiviral therapy for more than 6 months
for patients with compensated liver cirrhosis: HBV DNA≥4log copies/ml if HBeAg positive,HBV DNA≥3log copies/ml if HBeAg negative
for patients with uncompensated liver cirrhosis:HBV DNA positive

Exclusion criteria

coinfection with HCV,HDV and HIV
AFP≥100mg/L or HCC diagnosed by iconography
with severe cardiovascular, respiratory and endocrinology diseases or autoimmune diseases